DK2200593T5 - Hog-resistant pharmaceutical formulation - Google Patents

Hog-resistant pharmaceutical formulation Download PDF

Info

Publication number
DK2200593T5
DK2200593T5 DK08742137.6T DK08742137T DK2200593T5 DK 2200593 T5 DK2200593 T5 DK 2200593T5 DK 08742137 T DK08742137 T DK 08742137T DK 2200593 T5 DK2200593 T5 DK 2200593T5
Authority
DK
Denmark
Prior art keywords
coating
weight
amount
coated
api
Prior art date
Application number
DK08742137.6T
Other languages
Danish (da)
English (en)
Other versions
DK2200593T3 (en
Inventor
Walid Habib
Ehab Hamed
Zepeda Manuel A Vega
Original Assignee
Cima Labs Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/900,851 external-priority patent/US20080069891A1/en
Priority claimed from US12/075,543 external-priority patent/US8445018B2/en
Application filed by Cima Labs Inc filed Critical Cima Labs Inc
Publication of DK2200593T3 publication Critical patent/DK2200593T3/en
Application granted granted Critical
Publication of DK2200593T5 publication Critical patent/DK2200593T5/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
DK08742137.6T 2007-09-13 2008-03-19 Hog-resistant pharmaceutical formulation DK2200593T5 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US11/900,851 US20080069891A1 (en) 2006-09-15 2007-09-13 Abuse resistant drug formulation
PCT/US2007/020041 WO2008033523A1 (en) 2006-09-15 2007-09-14 Abuse resistant drug formulation
US12/075,543 US8445018B2 (en) 2006-09-15 2008-03-12 Abuse resistant drug formulation
PCT/US2008/003598 WO2009035474A1 (en) 2007-09-13 2008-03-19 Abuse resistant drug formulation

Publications (2)

Publication Number Publication Date
DK2200593T3 DK2200593T3 (en) 2016-10-03
DK2200593T5 true DK2200593T5 (en) 2016-12-12

Family

ID=39493594

Family Applications (1)

Application Number Title Priority Date Filing Date
DK08742137.6T DK2200593T5 (en) 2007-09-13 2008-03-19 Hog-resistant pharmaceutical formulation

Country Status (9)

Country Link
EP (1) EP2200593B1 (es)
JP (1) JP5730572B2 (es)
CA (1) CA2699142C (es)
DK (1) DK2200593T5 (es)
ES (1) ES2611794T3 (es)
HU (1) HUE032012T2 (es)
MX (1) MX336861B (es)
PL (1) PL2200593T3 (es)
WO (1) WO2009035474A1 (es)

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US20040234602A1 (en) 2001-09-21 2004-11-25 Gina Fischer Polymer release system
WO2003024430A1 (en) 2001-09-21 2003-03-27 Egalet A/S Morphine polymer release system
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
EP1610767B1 (en) 2003-03-26 2011-01-19 Egalet A/S Morphine controlled release system
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
NZ580972A (en) 2007-06-04 2012-02-24 Egalet Ltd Controlled release pharmaceutical compositions for prolonged effect
TWI454288B (zh) 2008-01-25 2014-10-01 Gruenenthal Chemie 藥物劑型
SI2273983T1 (sl) 2008-05-09 2016-11-30 Gruenenthal Gmbh Postopek za pripravo intermediatne praškaste formulacije in končne trdne odmerne oblike z uporabo stopnje strjevanja z razprševanjem
CA2751667C (en) 2009-02-06 2016-12-13 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
EP2445487A2 (en) 2009-06-24 2012-05-02 Egalet Ltd. Controlled release formulations
JP5667183B2 (ja) 2009-07-22 2015-02-12 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング 加熱溶融押出成型した制御放出性投与剤型
JP2012533585A (ja) 2009-07-22 2012-12-27 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング 酸化感受性オピオイドのための不正使用防止剤形
CA2784407A1 (en) 2009-12-17 2011-07-14 Cima Labs Inc. Abuse-resistant formulations
US20110150989A1 (en) * 2009-12-22 2011-06-23 Mallinkckrodt Inc. Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans
EP2538928B1 (en) * 2010-02-24 2017-05-03 Cima Labs Inc. Abuse-resistant formulations
US20130171256A1 (en) * 2010-05-11 2013-07-04 Cima Labs Inc. Alcohol-resistant extended release dosage forms comprising venlafaxine
US8927025B2 (en) * 2010-05-11 2015-01-06 Cima Labs Inc. Alcohol-resistant metoprolol-containing extended-release oral dosage forms
CA2798700C (en) * 2010-05-11 2018-08-21 Cima Labs Inc. Alcohol-resistant formulations
US9636303B2 (en) 2010-09-02 2017-05-02 Gruenenthal Gmbh Tamper resistant dosage form comprising an anionic polymer
ES2486791T3 (es) 2010-09-02 2014-08-19 Grünenthal GmbH Forma de dosificación resistente a la manipulación que comprende una sal inorgánica
US20130028972A1 (en) 2011-07-29 2013-01-31 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
AR087360A1 (es) 2011-07-29 2014-03-19 Gruenenthal Gmbh Tableta a prueba de manipulacion que proporciona liberacion de farmaco inmediato
BR112014019988A8 (pt) 2012-02-28 2017-07-11 Gruenenthal Gmbh Forma de dosagem resistente a socamento compreendendo um composto farmacologicamente ativo e um polímero aniônico
ES2692944T3 (es) 2012-04-18 2018-12-05 Grünenthal GmbH Forma de dosificación farmacéutica resistente a la manipulación y resistente a la descarga rápida de la dosis
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
CA2877183A1 (en) 2012-07-06 2014-01-09 Egalet Ltd. Abuse deterrent pharmaceutical compositions for controlled release
BR112015026549A2 (pt) 2013-05-29 2017-07-25 Gruenenthal Gmbh forma de dosagem à prova de violação contendo uma ou mais partículas
WO2014191396A1 (en) 2013-05-29 2014-12-04 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
CN105682643B (zh) 2013-07-12 2019-12-13 格吕伦塔尔有限公司 含有乙烯-醋酸乙烯酯聚合物的防篡改剂型
CA2931553C (en) 2013-11-26 2022-01-18 Grunenthal Gmbh Preparation of a powdery pharmaceutical composition by means of cryo-milling
AU2015261060A1 (en) 2014-05-12 2016-11-03 Grunenthal Gmbh Tamper resistant immediate release capsule formulation comprising Tapentadol
AU2015266117A1 (en) 2014-05-26 2016-11-24 Grunenthal Gmbh Multiparticles safeguarded against ethanolic dose-dumping
MX2017013637A (es) 2015-04-24 2018-03-08 Gruenenthal Gmbh Forma de dosificacion resistente a alteraciones con liberacion inmediata y resistencia contra la extraccion por solventes.
US10842750B2 (en) 2015-09-10 2020-11-24 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations

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Publication number Priority date Publication date Assignee Title
US5234957A (en) 1991-02-27 1993-08-10 Noven Pharmaceuticals, Inc. Compositions and methods for topical administration of pharmaceutically active agents
US5178878A (en) 1989-10-02 1993-01-12 Cima Labs, Inc. Effervescent dosage form with microparticles
US5223264A (en) 1989-10-02 1993-06-29 Cima Labs, Inc. Pediatric effervescent dosage form
US5266331A (en) * 1991-11-27 1993-11-30 Euroceltique, S.A. Controlled release oxycodone compositions
TW477708B (en) * 1996-09-13 2002-03-01 Shionogi & Amp Co Use of the thermal change to produce a substained release preparations and a process for their production
US6024981A (en) 1997-04-16 2000-02-15 Cima Labs Inc. Rapidly dissolving robust dosage form
CA2499994C (en) * 2002-09-23 2012-07-10 Verion, Inc. Abuse-resistant pharmaceutical compositions
KR100712356B1 (ko) * 2003-01-23 2007-05-02 (주)아모레퍼시픽 서방성 제제 및 그의 제조방법
CA2519556C (en) * 2003-04-21 2011-01-18 Benjamin Oshlack Tamper resistant dosage form comprising co-extruded, adverse agent particles and process of making same
TWI347201B (en) * 2003-04-21 2011-08-21 Euro Celtique Sa Pharmaceutical products,uses thereof and methods for preparing the same
DE10336400A1 (de) * 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
US20060263429A1 (en) * 2005-05-20 2006-11-23 Hengsheng Feng Compressible mixture, compressed pharmaceutical compositions, and method of preparation thereof

Also Published As

Publication number Publication date
EP2200593B1 (en) 2016-08-24
EP2200593A1 (en) 2010-06-30
ES2611794T3 (es) 2017-05-10
CA2699142C (en) 2016-05-17
PL2200593T3 (pl) 2017-02-28
WO2009035474A1 (en) 2009-03-19
DK2200593T3 (en) 2016-10-03
CA2699142A1 (en) 2009-03-19
JP2011517654A (ja) 2011-06-16
HUE032012T2 (en) 2017-08-28
MX2010002780A (es) 2010-05-17
MX336861B (es) 2016-02-04
JP5730572B2 (ja) 2015-06-10

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